This past Monday, the FDA approved Epidiolex, a marijuana derived CBD medication produced by GW Pharmaceuticals. Epidiolex – an oral solution for the treatment of certain forms of epilepsy – is the first FDA-approved drug that contains a purified derivative from marijuana. In approving Epidiolex, the FDA confirms that marijuana has medical benefits and applications, even though it remains a Schedule 1 controlled substance under the Controlled Substances Act.
Of note for producers of hemp oil and CBD products derived from hemp, FDA stated that it is “prepared to take action when [it] see[s] the illegal marketing of CBD-containing products with serious, unproven medical claims.” This, of course, is nothing new, and FDA has already sent out a number of cease and desist letters to companies making improper health and medical claims about their CBD products. Businesses marketing CBD products should continue to avoid making improper medical claims about their products.
FDA also said that “Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant.” That a product derived from marijuana would be a Schedule 1 controlled substance is uncontroversial. However, the approval, and FDA’s statements, create further confusion for producers of CBD derived from hemp.
Ultimately, FDA’s Epidiolex approval does little to change the hemp and CBD industry. There will continue to be risks associated with the production and sale of CBD as a result of disagreements between CBD businesses and DEA (as well as other federal agencies) regarding the meaning of industrial hemp under the Farm Bill.
This is likely the first step towards the FDA attempting to regulate fully the CBD compound altogether, and yet another reason for encouraging your Congressional representatives to support the McConnell version of the hemp provisions in the 2018 Farm Act, which clearly states that cannabinoids derived from hemp are lawful.
McAllister Garfield has been at the forefront to the hemp and CBD industry, assisting with compliance, risk mitigation, and company growth. If you have questions regarding the production and sale of CBD or other hemp products, please contact the Firm.
Garrett L. Davey, Esq.